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CMC Regulatory Executive
Location:
UK-Uxbridge
Jobcode:
7310
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CY Partners are currently looking for a CMC Regulatory Executive to come and join a leading global pharmaceutical organisation, at their site based in Uxbridge.

As a CMC Regulatory Executive, you will be responsible for identifying improvement opportunities for CMC Regulatory processes, policies and systems. Within this role you should demonstrate your knowledge and experience for EU and EMAP region. Work will be post approval and involves authoring of module 3 and CMC variations - previous experience of this is essential.

Other responsibilities include:

* Responding to manufacturing site change controls and providing regulatory advice and strategies

* Understanding CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.

* Managing multiple project assignments/teams simultaneously and provide data assessment and conclusions

* Identifying risks associated with submission data and information packages and ability to propose mitigation actions

This position is offered on a contract basis initially. It is an excellent opportunity for a Regulatory Executive to expand on their experience and work with a global company.

For a confidential chat about the role feel free to contact Helen at CY Partners or apply by sending across your CV

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